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Pilonidal DiseaseNCT01241136

Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

A study testing open wide-excision pilonidal cystectomy and minimal invasive pilonidal cystotomy in people with Pilonidal Disease, run by United States Naval Medical Center, Portsmouth at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In order to compare the early recurrence rates of pilonidal disease and overall patient satisfaction between procedures involving minimal and wide open excisions, we propose to perform a prospective, randomized clinical trial comparing these two surgical procedures. Read more about this study

Who is it for?
Ages 17 to 99 years
Conditions the study is for
Pilonidal Disease
What is being tested?
open wide-excision pilonidal cystectomy and minimal invasive pilonidal cystotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
19 Feb 2010to 16 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All patients who are scheduled for elective surgical treatment for their pilonidal disease

Who cannot join

  • 1. Any patient with active purulent infection (i.e. abscess). 2. Any patient who has had surgical intervention, excepting incisions and drainage for abscess for pilonidal disease.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Naval Medical Center Portsmouth

    Portsmouth, Virginia, 23708

Other trials in United States

About this study

Official title: Open Wide Excision Versus Minimal Surgery for Pilonidal Disease: A Randomized Control Trial Evaluating for Early Recurrence and Patient Satisfaction

In order to compare the early recurrence rates of pilonidal disease and overall patient satisfaction between procedures involving minimal and wide open excisions, we propose to perform a prospective, randomized clinical trial comparing these two surgical procedures. Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used for the procedure, the number of dressing changes, the length of convalescence, and overall patient tolerance of the procedures, both intra- and post-operatively. In addition, varying data points will be collected with the use of a quality of life survey and visual analog pain scale to analyze overall patient satisfaction. Patients will be followed for a period of two years following surgery to evaluate for early recurrence of their pilonidal disease.

Read the detailed description

Pilonidal disease, a chronic infection involving the skin and subcutaneous tissues along the sacrococcygeal area (natal cleft) is a common disease affecting mostly young adult males who make up the majority of our military workforce. Surgical treatment options for pilonidal disease vary widely from the invasive (e.g. wide open excisions) to minimally invasive procedures (e.g. removal of lined sinus tracts using minimal excisions) as well as other popular treatments involving myocutaneous or skin flaps (Limberg flap and Z-plasty). All of these surgical procedures are associated with varying degrees of early and late recurrence rates; however, the current, more popular procedure for the treatment of pilonidal disease involves wide open excisions.

A recent advancement in the minimally invasive surgical technique for pilonidal disease involves the use of Keyes trephines (a 2-to-9 mm diameter biopsy instrument) to excise the individual pits and to drain the cyst cavities. Although this procedure has been proven to be effective against pilonidal disease with an overall low early recurrence rate, no clinical trial has been performed to rate this procedure of minimal excisions against the current, more common procedure of wide open excisions. A recent report has suggested that the recurrence rate of pilonidal disease for minimal excisions may be comparable to that of wide excisions. Furthermore, reports have also suggested that this minimally invasive procedure can be performed with minimal (and possibly local) anesthesia, less post-operative pain medication, and may involve a shorter convalescence time for patients.

In order to compare the early recurrence rates of pilonidal disease and overall patient satisfaction between procedures involving minimal and wide open excisions, we propose to perform a prospective, randomized clinical trial comparing these two surgical procedures. Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used for the procedure, the number of dressing changes, the length of convalescence, and overall patient tolerance of the procedures, both intra- and post-operatively. In addition, varying data points will be collected with the use of a quality of life survey and visual analog pain scale to analyze overall patient satisfaction. Patients will be followed for a period of two years following surgery to evaluate for early recurrence of their pilonidal disease.

Being tested
open wide-excision pilonidal cystectomy, minimal invasive pilonidal cystotomy
Keywords
pilonidal disease, cystectomy, recurrence
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open wide-excision pilonidal cystectomyProcedure or surgery

    traditional open wide-excisional pilonidal cystectomy

  • minimal invasive pilonidal cystotomyProcedure or surgery

    unroofing the cyst cavity and curettage the cyst

Study groups in NCT01241136
Study groupRoleWhat they receive
Open traditional pilonidal cystectomyPlacebo comparatortraditional complete wide-excision pilonidal cystectomy
Receives: Procedure: open wide-excision pilonidal cystectomy
Minimal invasive pilonidal cystotomyExperimentalUsing only Keyes Trephines to unroof and curette the pilonidal cyst cavity
Receives: Procedure: minimal invasive pilonidal cystotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of early recurrence

    After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease

    Measured: 2 years

Secondary outcomes (2)
  1. Tolerance of the procedure

    Determine wound healing times and amount of convalescence associated with each procedure

    Measured: 30 days

  2. Patient satisfaction

    Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2010 (estimated)
  2. Study start19 Feb 2010
  3. Primary completion25 Nov 2014
  4. Study completion16 Jul 2025

Why it stopped: No recruitment occurred and the PI stopped the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01241136
Sponsor's protocol ID
CIP# 10.0041
Status last verified
Oct 2025
First submitted
15 Nov 2010
Last updated
9 Oct 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing open wide-excision pilonidal cystectomy and minimal invasive pilonidal cystotomy in people with Pilonidal Disease, run by United States Naval Medical Center, Portsmouth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of early recurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.

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